MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10012144
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris administration set experienced flow issues.The following information was provided by the initial reporter: back check valve failure.Connected was a non-vented secondary set.The secondary bag contents (antibiotic) backed up into the primary bag and they said the drip chamber was full.This happened in the bone marrow transplant unit.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the secondary bag contents backed up into the primary bag could not be verified due to the product not being returned for failure investigation.A dhr was performed for the possible lots.A device history record review for model 2426-0007 lot number 21086155 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2426-0007 lot number 21086155 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd alaris administration set experienced flow issues.The following information was provided by the initial reporter: back check valve failure.Connected was a non-vented secondary set.The secondary bag contents (antibiotic) backed up into the primary bag and they said the drip chamber was full.This happened in the bone marrow transplant unit.

• Brand Name: BD ALARIS ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12801076
• Report Number: 9616066-2021-52414
• Device Sequence Number: 5575278
• Product Code: FPA
• UDI-Device Identifier: 37613203021167
• UDI-Public: 37613203021167
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 10012144
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown